What is an Exemption Determination Request?

Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(b) (federally funded projects), 21 CFR 56.104(d) (FDA regulated studies), and the Tri-Council Policy Statement (TCPS 2), Article 2 (Canadian Research). An applicant may therefore apply to Quorum Review for an exemption determination.